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| Name | Class |
|---|---|
| iOMEDICO AG, Freiburg, Germany | UNKNOWN |
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The objectives of this study are to assess molecular testing, treatment patterns, and associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor) mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability of a third-generation TKI (primary study cohort). Additionally, molecular testing and treatment patterns will be assessed among a secondary cohort of patients which will include patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Study Cohort | Patients with prior confirmed EGFR mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (Epidermal Growth Factor Receptor - Tyrosine Kinase Inhibitor) therapy | ||
| Secondary Study Cohort | Patients diagnosed with de-novo (wild-type) EGFR T790M mutation-positive (alone or in combination with other mutations) locally advanced or advanced NSCLC |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate molecular testing patterns among patients with EGFR mutation-positive locally advanced or advanced NSCLC | Molecular testing patterns including: Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients in the primary study cohort (applicable to patients in the primary study cohort); Change in testing rates over time - testing rate over time will be described; Molecular testing details including sample type, method of biopsy, testing turnaround time, test type, reason for testing, testing laboratory type, reason for not performing a test; Molecular testing results including mutation status and type, test outcome, histologic/phenotypic transformation; | Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months |
| To assess treatment patterns and associated clinical outcomes among patients with EGFR mutation-positive locally advanced or advanced NSCLC | Treatment patterns and associated clinical outcomes including: Overall survival measured from: date of initial diagnosis to date of death from any cause (for primary and secondary cohorts), date of progression to date of death from any cause (for primary cohort only); Time to initiation of new therapy defined as the time from start date of current therapy to start date of subsequent therapy; Treatment(s) received post diagnosis and post progression including chemotherapy, radiation, surgery, targeted therapy, immunotherapy; Treatment sequence patterns, line(s) of therapy, treatment regimen(s), treatment duration, number of cycles; | Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess health care utilization patterns | Health care utilization patterns will be presented by the following care settings: hospitalization and length of stay, emergency room and physician office visits | Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months |
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Inclusion Criteria - Primary Study Cohort
Inclusion Criteria - Secondary Study Cohort
Exclusion Criteria - Primary and Secondary Study Cohorts
• Enrollment in studies that prohibit any participation in this non-interventional study. These patients will be censored.
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800 patients across both cohorts - 700 patients primary cohort and 100 patients secondary cohort. Patients will be recruited from approximately 100 participating sites in Germany (70 hospitals and 30 outpatient practices).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aschaffenburg | D5160R00005 | Germany | |||
| Research Site |
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| Label | URL |
|---|---|
| Redacted CSR Synopsis | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| To assess treatment related complications |
Assessment of treatment related complications observed with chemotherapy and targeted therapies among patients with NSCLC. |
| Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months |
| To assess biopsy related complications | Assessment of biopsy related complications for each documented biopsy procedure | Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months |
| To document rate of central nervous system (CNS) metastases | Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months |
| Assessment of health-related quality of life (HRQoL) | Health related quality of life (HRQoL): Assessment of general cancer-associated and specific lung cancer associated parameters by use of standardized HRQoL questionnaires:
| Date of first visit to last visit. HRQoL are collected every 6 months (plus or minus 1.5 months) up to 36 months |
| Augsburg |
| D5160R00005 |
| Germany |
| Research Site | Bad Kreuznach | D5160R00005 | Germany |
| Research Site | Ballenstedt | D5160R00005 | Germany |
| Research Site | Bautzen | D5160R00005 | Germany |
| Research Site | Berlin | D5160R00005 | Germany |
| Research Site | Bochum | D5160R00005 | Germany |
| Research Site | Bonn | D5160R00005 | Germany |
| Research Site | Bottrop | D5160R00005 | Germany |
| Research Site | Bremen | D5160R00005 | Germany |
| Research Site | Celle | D5160R00005 | Germany |
| Research Site | Cologne | D5160R00005 | Germany |
| Research Site | Dresden | D5160R00005 | Germany |
| Research Site | Düsseldorf | D5160R00005 | Germany |
| Research Site | Erfurt | D5160R00005 | Germany |
| Research Site | Esslingen am Neckar | D5160R00005 | Germany |
| Research Site | Frankfurt (Oder) | D5160R00005 | Germany |
| Research Site | Freiburg i.Br. | D5160R00005 | Germany |
| Research Site | Freital | D5160R00005 | Germany |
| Research Site | Fürth | D5160R00005 | Germany |
| Research Site | Gauting | D5160R00005 | Germany |
| Research Site | Georgsmarienhütte | D5160R00005 | Germany |
| Research Site | Goslar | D5160R00005 | Germany |
| Research Site | Göttingen | D5160R00005 | Germany |
| Research Site | Greifenstein | D5160R00005 | Germany |
| Research Site | Güstrow | D5160R00005 | Germany |
| Research Site | Gütersloh | D5160R00005 | Germany |
| Research Site | Halle | D5160R00005 | Germany |
| Research Site | Hamburg | D5160R00005 | Germany |
| Research Site | Hanover | D5160R00005 | Germany |
| Research Site | Heidenheim | D5160R00005 | Germany |
| Research Site | Herne | D5160R00005 | Germany |
| Research Site | Hildesheim | D5160R00005 | Germany |
| Research Site | Hof | D5160R00005 | Germany |
| Research Site | Kaiserslautern | D5160R00005 | Germany |
| Research Site | Karlsruhe | D5160R00005 | Germany |
| Research Site | Kempten | D5160R00005 | Germany |
| Research Site | Koblenz | D5160R00005 | Germany |
| Research Site | Krefeld | D5160R00005 | Germany |
| Research Site | Landshut | D5160R00005 | Germany |
| Research Site | Lebach | D5160R00005 | Germany |
| Research Site | Leipzig | D5160R00005 | Germany |
| Research Site | Löwenstein | D5160R00005 | Germany |
| Research Site | Ludwigsburg | D5160R00005 | Germany |
| Research Site | Mainz | D5160R00005 | Germany |
| Research Site | Mönchengladbach | D5160R00005 | Germany |
| Research Site | Muehlheim A.d. Ruhr | D5160R00005 | Germany |
| Research Site | München | D5160R00005 | Germany |
| Research Site | Münnerstadt | D5160R00005 | Germany |
| Research Site | Naunhof | D5160R00005 | Germany |
| Research Site | Neustadt a.R. | D5160R00005 | Germany |
| Research Site | Nuremberg | D5160R00005 | Germany |
| Research Site | Offenburg | D5160R00005 | Germany |
| Research Site | Oldenburg | D5160R00005 | Germany |
| Research Site | Osnabrück | D5160R00005 | Germany |
| Research Site | Pirna | D5160R00005 | Germany |
| Research Site | Porta Westfalica | D5160R00005 | Germany |
| Research Site | Ratingen | D5160R00005 | Germany |
| Research Site | Ravensburg | D5160R00005 | Germany |
| Research Site | Rosenheim | D5160R00005 | Germany |
| Research Site | Rostock | D5160R00005 | Germany |
| Research Site | Schorndorf | D5160R00005 | Germany |
| Research Site | Stolberg | D5160R00005 | Germany |
| Research Site | Stuttgart | D5160R00005 | Germany |
| Research Site | Twistringen | D5160R00005 | Germany |
| Research Site | Völklingen | D5160R00005 | Germany |
| Research Site | Wangen | D5160R00005 | Germany |
| Research Site | Westerstede | D5160R00005 | Germany |
| Research Site | Wiesbaden | D5160R00005 | Germany |
| Research Site | Witten | D5160R00005 | Germany |
| Research Site | Würselen | D5160R00005 | Germany |
| Research Site | Würzburg | D5160R00005 | Germany |
| Research Site | Zittau | D5160R00005 | Germany |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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